Managing Your FDA "483" Inspectional Observations - Recorded Webinar

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Casper (Cap) Uldriks

OVERVIEW:
The FDA list of inspectional observations (aka 483) tells the FDA the kinds of deviations a firm has and how serious they are. The 483 and the inspection report provide the factual foundation for the FDA to determine whether official action is appropriate.

Ideally you will not receive a 483, which for the moment indicates you appear to be in substantial compliance. However, a 483 is usually issued and can represent a firm in a minor state of regulatory deficiency all the way to it is evidence that what the firm is doing presents an urgent public health risk. The 483 covers a broad gradation of problems, both in number and the in the seriousness nature of a particular regulation. Interpreting a 483 and correcting the problems noted on a 483 requires an intelligent strategy in order to be cost effective and mitigate your regulatory risks as quickly as possible. How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your favor as it is well organized, succinct and provides proper documentation.

Managing a 483 becomes a "package deal" that will have a life of its own long after the inspection. The 483 paints of picture of the firm. Your job is to make that picture look as good as possible.

Why You Should Attend: Your failure to understand and properly respond to a 483 issued to you at the conclusion of an FDA inspection may quickly lead to an administrative or a legal action that can have an immediate adverse effect on a firm’s business. If you do not understand what a 483 is saying, if you don’t respond in writing to the FDA in a very short timeframe, you are walking down a path that places a hammer over your firm.

You cannot afford to make mistakes or "wing it" when the FDA investigator informs you that it looks like you have a problem. Some problems are worse than others. You need to understand how FDA evaluates 483 observations and how you can evaluate your 483 to figure out how likely it is that the FDA plans to take a follow up action against the firm. The webinar will include practical tips of how to manage a 483 during an inspection and after an inspection. You will be provided references to the FDA’s standard procedures related to 483w and how the agency determines what follow up it will take based on the 483.

The FDA uses criteria that you can use to approximate the outcome. You also need to understand what your responsibilities are to rehabilitate of regulatory program and what the FDA will do during the next inspection.

Areas Covered in the Session:
- What the 483 means
- How to interpret the 483 - "How bad is it?"
- Managing the 483 discussion with the FDA at the conclusion of the inspection
- Responding to the FDA in writing
- Use of a Corrective and Preventive Action program
- What to expect during the next FDA inspection

SPEAKER PROFILE:
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

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